Trial Condition(s):
Diabetes Mellitus
Prevention of postprandial hyperglycemia by acarbose may be a promising therapeutic strategy for reducing the increased risk for cardiovascular disease (ABDOMEN)
Bayer Identifier:
13066
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
The use of acarbose in impaired glucose tolerance (IGT) and type 2 diabetic subjects has been associated with a significant reduction of cardiovascular events. Additionally, acarbose has been shown to have a beneficial influence on some of the other cardiovascular risk factors (metabolic syndrome components). Thus, prevention of postprandial hyperglycemia by acarbose may be a promising therapeutic strategy for reducing the increased risk for cardiovascular disease. Further studies are needed to confirm the influence of acarbose on cardiovascular risk factors in the real life setting.
Inclusion Criteria
- Diabetes Mellitus - Age >/= 18 years - Naive to acarbose (minimum 3 months before inclusion)
Exclusion Criteria
- Hypersensitivity to acarbose or any of the excipients - Age <18 years - Pregnancy and in nursing - Inflammatory bowel disease, colonic ulceration, partial intestinal obstruction or in patients predisposed to intestinal obstruction - Chronic intestinal diseases associated with marked disorders of digestion or absorption - States which may deteriorate as a result of increased gas formation in the intestine, (e.g. Roemheld’s syndrome [an angina pectoris-like syndrome or aggravation of an angina pectoris due to the postprandial filling of the stomach] and larger hernias) - Hepatic and severe renal impairment (creatinine clearance <25 mL/min/ 1,73m2)
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Investigative Site Many Locations, Poland | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
Acarbose in cardiovascular risk management. Assessment of clinical efficacy and safety of acarbose and its effect on selected cardiovascular risk factors in type 2 diabetes patients.
Trial Type:
Observational
Intervention Type:
Drug
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
1
Primary Outcome
- Safety, tolerability of acarbose and its effect on body weight, waist circumference and blood pressureTimeframe: approximately 6 months after acarbose treatment initiation
Secondary Outcome
- Effect of acarbose on HbA1c, fasting and postprandial glycemia and on lipid profileTimeframe: approximately 6 months after acarbose treatment initiation
Additional Information
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